Methods for replacing a cardiac valve

• US 10,583,001 B2
• Filed: 10/08/2013
• Issued: 03/10/2020
• Est. Priority Date: 02/18/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose L., Navia, Jose A., Oberti, Carlos
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US14/048,987
• Publication Number:
  US 20140039613A1
• Time in Patent Office: 2,345 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

Abstract

A method for replacing a cardiac valve includes an expandable support member having oppositely disposed first and second ends, a main body portion extending between the ends, and a prosthetic valve within the main body portion. The main body portion has an annular shape for expanding into position in the annulus of the valve. The first and second ends include a plurality of upper and lower wing members movable from a collapsed condition into an extended condition for respectively engaging a first section of cardiac tissue surrounding the valve and for: engaging a portion of the native valve leaflets to pin the leaflets back against the annulus. The second end further includes at least two strut members spaced apart from each other. A respective one of the strut members is attached to at least one commissural section of the prosthetic valve to prevent prolapse of the valve leaflets.

Claims

1. A method for replacing a native cardiac valve having at least two native valve leaflets, said method comprising:

providing a prosthetic valve that includes an expandable support member having oppositely disposed first and second ends and a main body portion extending between the first and the second ends, and having a biocompatible material covering an entire circumference of an inside surface thereof, a plurality of upper wing members that extend integrally from the first end of the support member and are spaced about the circumference of the main body portion, and a plurality of lower wing members that extend integrally from the second end of the support member, wherein the expandable support member further comprises at least two strut members spaced apart from each other and physically attached to the prosthetic valve along at least two commissural sections;

temporarily holding the upper wing members and the lower wing members in a radially collapsed configuration during surgery;

expanding the expandable support member to physically engage a circumferential region of the support member with an annulus of the native cardiac valve to exert sufficient force to pin the native leaflets against the annulus of the cardiac valve;

releasing a plurality of constraining wires to allow the upper and the lower wing members to expand radially outward to an expanded configuration, wherein the upper wing members are transverse to the direction of blood flow; and

securing the prosthetic valve in the annulus of the native cardiac valve such that the upper wing members expand to physically contact a first section of cardiac tissue spaced away from the native leaflets and surrounding the annulus of the native cardiac valve.

2. The method of claim 1, wherein (1) engagement of the circumferential region of the support member with the leaflets of the native cardiac valve, (2) engagement of the upper wing members with the first section of cardiac tissue spaced away from the native leaflets and (3) engagement of the lower wing members with the native valve annulus establishes an integral three-way locking mechanism securing the prosthetic valve to the first section of cardiac tissue and to the annulus of the native cardiac valve.

3. The method of claim 1, wherein deployment of a separate attachment mechanism from the upper wing members-embeds the separate attachment mechanism into the first section of cardiac tissue spaced away from the native leaflets.

4. The method of claim 3, wherein the separate attachment mechanism includes at least one barb and said method comprises embedding the at least one barb into the first section of cardiac tissue.

5. The method of claim 1, wherein a step of actuating the plurality of constraining wires moves the upper wing members into direct contact with a wall of the left atrium.

6. The method of claim 1, wherein the step of releasing the constraining wires positions each of the upper wing members radially outward to engage the first section of cardiac tissue spaced away from the native leaflets and positions the lower wing members to engage the native valve annulus.

7. The method of claim 6, wherein the first section of cardiac tissue is a wall of the left atrium.

8. The method of claim 1, wherein a step of inserting the prosthetic valve into the annulus of the native cardiac valve is done via a jugular vein.

9. The method of claim 1, wherein at least a portion of the expandable support member is treated with a therapeutic agent for eluting into cardiac tissue proximate to the expandable support member.

10. The method of claim 1, wherein the prosthetic valve is comprised of at least one suture attachment mechanism and the method further comprises releasing a suture connected to the suture attachment mechanism.

11. The method of claim 1, wherein a tissue portion of the prosthetic valve is constructed of a single piece of pericardial tissue.

12. The method of claim 1, wherein a tissue component of the prosthetic valve is treated with a dry tissue valve procedure and an anti-calcification solution.